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NCT02348593 · ClinicalTrials.gov registry record · Phase 3

"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"

A Phase 3 study, sponsored by Jazz Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
239
Enrollment target

NCT02348593: Completed Phase 3 study, sponsored by Jazz Pharmaceuticals.

NCT02348593 is a Phase 3 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 239 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02348593, a Phase 3 study, has completed, sponsored by Jazz Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
239 participants
Enrollment target

Study Summary

This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.

Primary Outcome

Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing.

Interventions

  • DRUG Placebo oral tablet
  • DRUG JZP-110

Trial Details

FieldValue
Enrollment Target 239 participants
Start Date 2015-05
Est. Completion 2017-02
Phase Phase 3
Jazz Pharmaceuticals

128 total trials

What the finished NCT02348593 record still lists

NCT02348593 is an interventional study that assigns participants to a tested intervention. The registered 239 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.

NCT02348593 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02348593 about?

NCT02348593 is a clinical study titled ""Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"". This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.

What is the current status of trial NCT02348593?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 239 participants. The study started on 2015-05. Estimated completion is 2017-02.

What interventions are being tested in trial NCT02348593?

The interventions under investigation include: Placebo oral tablet (DRUG), JZP-110 (DRUG).

Who is sponsoring clinical trial NCT02348593?

This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02348593's enrollment target sits among peer trials

239 1291st of 2000 higher than 710 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02348593, the US trial registry maintained by the National Library of Medicine. NCT02348593 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.